Part 11 Comments

1
Part 11 Comments

• Dr Guy Wingate
• Chairman - GAMP Council
• guy.wingate_at_gsk.com

2
GAMP Forum

• Technical Sub-Committee of ISPE
• GAMP Forum is international organisation with
  active regional steering committees for USA,
  Europe, and Japan
• Membership includes pharmaceutical companies,
  suppliers, consultants and regulators
• Responsible for GAMP4 Guide and working on new
  Electronic Record/Signature Guidance

3
Scope of Presentation

• Part 11 applies to all FDA regulated industries
• This presentation is largely based on a
  pharmaceutical sector perspective
• We believe the points made here are equally
  applicable to the other sectors

4
Top Recommendations

• 1) Align the Rule with the intent of FDAs
  Part 11 Final Guidance on Scope and
  Application
• Preserve and clarify narrow scope
• Focus on signatures and records, not systems or
  data
• Emphasize predicate rules
• 2) Application and rigor for all controls can
  be based on impact and risk
• 3) Computer systems validation expected but
  commensurate with impact

5
Potential Part 11 Rulemaking

• Part 11 Rule should concentrate on what is needed
  and avoid being prescriptive on how to fulfil
  Part 11 Rule
• If risk based approach is used then it should be
  defined and documented by user organisation
• Keep new preamble to any Part 11 revision short.
  If additional guidance is needed then should be
  made as separate guidance document

6
Conclusion

• We believe FDAs current thinking on Part 11 is
  much more consistent with other ERS
  international regulations affecting electronic
  records and signatures
• We believe current FDA thinking on Part 11 should
  help facilitate new technology and innovation
  (e.g. PAT)
• Part 11 Rule needs to be revised to align it with
  Final Guidance